Trial · NCT00166166
Endothelial Hyperpolarization in Humans
NCT00166166, Phase 2, Terminated, Emory University; results first posted 2015-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Endothelial Hyperpolarization in Humans. Trials, record NCT00166166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00166166
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Endothelial Hyperpolarization in Humans
- NCT number
- NCT00166166
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 174 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Hyperlipidemia
- Interventions
- Tetraethylammonium (TEA), L-NG-monomethyl Arginine (L-NMMA), Bradykinin, Sodium nitroprusside, Acetylcholine, Saline, Fluconazole
- First posted
- 2005-09-14
- Last updated
- 2018-08-15
- Results first posted
- 2015-05-13
- Limitations and caveats
Findings are limited to the forearm microcirculations, thus other vascular beds including conductance arteries warrant further investigation. Nevertheless, it is known that the contribution of EDHF is less in conductance vessels than in microvessels.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration | Baseline, 5 minutes | Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after TEA administration. |
| Primary | Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) | Baseline, 5 minutes | Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from baseline and after L-NMMA administration. |
| Secondary | Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA) | 5 minutes, 10 minutes | Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from after L-NMMA administration and after TEA administration. |
| Secondary | Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration | Baseline, 5 minutes | Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after fluconazole administration. |
| Secondary | Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration | 5 minutes, 10 minutes | Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after L-NMMA administration and administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF after L-NMMA administration and then fluconazole administration. |
| Secondary | Percent Change in Forearm Blood Flow (FBF) After Fluconazole and Tetraethylammonium (TEA) Administration | 5 minutes, 10 minutes | Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of fluconazole and Tetraethylammonium (TEA) administration. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from FBF after fluconazole administration and after Tetraethylammonium (TEA) administration. |
| Secondary | Forearm Blood Flow (FBF) After Sodium Nitroprusside Administration | 5 minutes | Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of sodium nitroprusside. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. |
| Secondary | Change in Tissue Plasminogen Activator (t-PA) Release | Baseline, 30 minutes | Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \[101-hematocrit/100\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA at baseline and t-PA after bradykinin 400 ng/min |
| Secondary | Change in Tissue Plasminogen Activator (t-PA) Release After Tetraethylammonium (TEA) and Bradykinin Administration | 30 minutes, 60 minutes | Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \[101-hematocrit/100\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after Tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min |
| Secondary | Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole and Bradykinin Administration | 30 minutes, 60 minutes | Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x \[101-hematocrit/100\]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and t-PA after bradykinin 400 ng/min |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration | Baseline, 5 minutes | Only 62 of the original 174 subjects were treated for this portion of the study. | percent change | MEAN |
| PRIMARY | Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) | Baseline, 5 minutes | Only 62 of the original 174 subjects were treated for this portion of the study. | percent change | MEAN |
| SECONDARY | Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA) | 5 minutes, 10 minutes | Only 62 of the original 174 subjects were treated for this portion of the study. | percent change | MEAN |
| SECONDARY | Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration | Baseline, 5 minutes | Only 33 of the original 174 subjects were treated for this portion of the study. | percent change | MEAN |
| SECONDARY | Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration | 5 minutes, 10 minutes | Only 15 of the original 174 subjects were treated for this portion of the study. | percent change | MEAN |
| SECONDARY | Percent Change in Forearm Blood Flow (FBF) After Fluconazole and Tetraethylammonium (TEA) Administration | 5 minutes, 10 minutes | Only 19 of the original 174 subjects were treated for this portion of the study. | percent change | MEAN |
| SECONDARY | Forearm Blood Flow (FBF) After Sodium Nitroprusside Administration | 5 minutes | Only 80 of the original 174 subjects were treated for this portion of the study. | mL min^-1 * 100 mL^-1 | MEAN |
| SECONDARY | Change in Tissue Plasminogen Activator (t-PA) Release | Baseline, 30 minutes | Only 33 of the original 174 subjects were treated for this portion of the study. | ng/mL | MEAN |
| SECONDARY | Change in Tissue Plasminogen Activator (t-PA) Release After Tetraethylammonium (TEA) and Bradykinin Administration | 30 minutes, 60 minutes | Only 18 of the original 174 subjects were treated for this portion of the study. | ng/mL | MEAN |
| SECONDARY | Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole and Bradykinin Administration | 30 minutes, 60 minutes | Only 11 of the original 174 subjects were treated for this portion of the study. | ng/mL | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration | Healthy Controls | -18 | Standard Error 16 | percent change | |
| Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration | Risk Factors | -24 | Standard Error 13 | percent change | |
| Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) | Healthy Controls | -29 | Standard Error 17 | percent change | |
| Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) | Risk Factors | -23 | Standard Error 15 | percent change | |
| Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA) | Healthy Controls | -38 | Standard Error 17 | percent change | |
| Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA) | Risk Factors | -39 | Standard Error 17 | percent change | |
| Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration | Healthy Controls | -13 | Standard Error 16 | percent change | |
| Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration | Risk Factors | -17 | Standard Error 13 | percent change | |
| Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration | Healthy Controls | -26 | Standard Error 22 | percent change | |
| Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration | Risk Factors | -26 | Standard Error 22 | percent change |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Healthy Controls | 103 | |
| Overall Study | STARTED | Risk Factors | 71 | |
| Overall Study | COMPLETED | Healthy Controls | 103 | |
| Overall Study | COMPLETED | Risk Factors | 71 | |
| Overall Study | NOT COMPLETED | Healthy Controls | 0 | |
| Overall Study | NOT COMPLETED | Risk Factors | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Healthy Controls | ||
| Total, all-cause mortality | Risk Factors | ||
| Total, other adverse events | Healthy Controls | 0 | 103 |
| Total, other adverse events | Risk Factors | 0 | 71 |
| Total, serious adverse events | Healthy Controls | 0 | 103 |
| Total, serious adverse events | Risk Factors | 0 | 71 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL079115 | Endothelial Hyperpolarization in Humans | QUYYUMI, ARSHED A | EMORY UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2005 to 2008 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Healthy Controls vs Risk Factors: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00166166
GET https://conductscience.org/api/trials/v1/NCT00166166/registered